BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DA VINCI

    MDR report key: 22108844 · Received May 29, 2025

    Report

    Report Number
    2955842-2025-22692
    Event Type
    Injury
    Date Received
    May 29, 2025
    Date of Event
    April 24, 2025
    Report Date
    May 8, 2025
    Manufacturer
    INTUITIVE SURGICAL, INC
    Product Code
    NAY
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    INTUITIVE SURGICAL, INC. (ISI) DID NOT RECEIVE THE DA VINCI PRODUCT WITH AN ALLEGED ISSUE TO PERFORM FAILURE ANALYSIS. ALTHOUGH THE COMPLAINT WAS NOT CONFIRMED BY FAILURE ANALYSIS SINCE THE PRODUCT WAS NOT RETURNED, THE INFORMATION GATHERED INDICATES THAT THE DEVICE MAY HAVE CONTRIBUTED TO THE CUSTOMER REPORTED ISSUE.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT AFTER A DA VINCI-ASSISTED PULMONARY WEDGE RESECTION SURGICAL PROCEDURE, A ROUTINE CT SCAN WAS PERFORMED, AND A FRAGMENT WAS FOUND IN THE PATIENT. THE CUSTOMER WAS UNSURE IF A FRAGMENT CAME OF INTUITIVE SURGICAL, INC. (ISI) INSTURMENT OR ACCESSORY. FRAGMENT HAS NOT BEEN RETRIEVED YET. THE CUSTOMER WAS PLANNING NEXT STEPS. THE PROCEDURE WAS COMPLETED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    625794 DA VINCI UNKNOWN NAY INTUITIVE SURGICAL, INC N/A N/A

    Patients

    Seq Age Sex Outcome Treatment
    1 16 YR Unknown Required Intervention DA VINCI INSTRUMENTS AND ACCESSORIES